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NCT07082972
EMG-Based Evaluation of Occlusal Splint and Masseter Botox Effects on Head and Neck Muscles
Phase 4 trial testing Botulinum toxin injection in Myofascial Pain Syndrome (MPS) in 56 participants. Currently enrolling.
1 September 2026
Quick facts
| Lead sponsor | Istanbul University |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 56 |
| Start date | 1 September 2025 |
| Primary completion | 1 September 2026 |
| Estimated completion | 1 December 2026 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Botulinum toxin injection
- Occlusal splint
- Botulinum toxin + Occlusal splint combined
Conditions studied
- Myofascial Pain Syndrome (MPS) — all drugs for Myofascial Pain Syndrome (MPS) →
- Masticatory Muscle Pain — all drugs for Masticatory Muscle Pain →
Sponsor
Istanbul University
Who can join
Adults 18 to 55, any sex, with Myofascial Pain Syndrome (MPS) or Masticatory Muscle Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This randomized controlled clinical trial aims to evaluate the individual and combined effects of occlusal splint therapy and botulinum toxin type A (BTX-A) injections into the masseter muscle on the activity of head and neck muscles in patients diagnosed with myofascial pain syndrome (MPS). MPS is a common subtype of temporomandibular disorders (TMD), frequently involving the masticatory and cervical muscles. Despite various treatment modalities, there is still no universally accepted protocol. In this study, 56 adult participants of both sexes, without missing teeth and within a normal body mass index (BMI) range, will be randomly assigned to four groups: BTX-A injection only, occlusal splint only, combined BTX-A and splint therapy, and an untreated control group. Surface electromyography (EMG) will be used to assess muscle activity in the masseter, temporalis, sternocleidomastoid, splenius capitis, and trapezius muscles. EMG recordings will be performed at baseline, 4 weeks, and 12 weeks after the intervention. Pain levels and symptom severity will be assessed using the DC/TMD symptom questionnaire and the Visual Analog Scale (VAS). BTX-A injections will be administered by a neurology specialist (20 IU per masseter muscle), and occlusal splints will be custom-fabricated and fitted for each participant. This study seeks to determine the neuromuscular effects of these treatments-both alone and in combination-on masticatory and cervical muscles and to provide insight into the development of more comprehensive and effective treatment strategies for MPS.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07082972
- Europe PMC full search
- ASCO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07082972 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istanbul University
- Last refreshed: 24 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07082972.
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